Table 3. Overview of Adverse Events (Safety Population)*.
| Event | 177Lu-Dotatate Group (N = 111) | Control Group (N = 110) | P Value† |
|---|---|---|---|
| number of patients (percent) | |||
|
| |||
| Adverse event | |||
|
| |||
| Any | 106 (95) | 95 (86) | 0.02 |
| Related to treatment | 95 (86) | 34 (31) | <0.001 |
|
| |||
| Serious adverse event | |||
|
| |||
| Any | 29 (26) | 26 (24) | 0.76 |
| Related to treatment | 10 (9) | 1 (1) | 0.01 |
|
| |||
| Withdrawal from trial because of adverse event | |||
|
| |||
| Because of any adverse event | 7 (6) | 10 (9) | 0.46 |
| Because of adverse event related to treatment | 5 (5) | 0 | 0.06 |
The safety population included all patients who underwent randomization and received at least one dose of trial treatment.
P values were calculated with the use of Fisher's exact text.